Gerd treatment apparatus and method

ABSTRACT

An apparatus includes an expandable member. The expandable member is sized to be positionable in a sphincter. An energy delivery device is positioned on a surface of the expandable member. The energy delivery device has a configuration that provides sufficient energy delivery to create lesions in the interior of the sphincter. When the expandable member is removed from the sphincter, the sphincter returns to its closed or contracted configuration.

CROSS-RELATED APPLICATIONS

[0001] This application is a continuation-in-part of U.S. patentapplication Ser. No. 08/731,372, filed Oct. 11, 1996, which is acontinuation-in-part of U.S. patent application Ser. No. 08/319,373,filed Oct. 6, 1994, which is a continuation-in-part of U.S. applicationSer. No. 08/286,862, filed Aug. 4, 1994, which is a continuation-in-partof U.S. patent application Ser. No. 08/272,162, filed Jul. 7, 1994,which is a continuation-in-part of U.S. patent application Ser. No.08/265,459, filed Jun. 24, 1994, and is related to concurrently filedApplication entitled “GERD Treatment Apparatus and Method” identified asAttorney Docket 14800-748, all with named inventor Stuart D. Edwards,and all of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] This invention relates generally to an apparatus and method forthe treatment of sphincters, and more specifically to an apparatus andmethod that treat esophageal sphincters.

[0004] 2. Description of Related Art

[0005] Gastroesophageal reflux disease (GERD) is a commongastroesophageal disorder in which the stomach contents are ejected intothe lower esophagus due to a dysfunction of the lower esophagealsphincter (LES). These contents are highly acidic and potentiallyinjurious to the esophagus resulting in a number of possiblecomplications of varying medical severity. The reported incidence ofGERD in the U.S. is as high as 10% of the population (Castell D O;Johnston B T: Gastroesophageal Reflux Disease: Current Strategies ForPatient Management. Arch Fam Med, 5(4):221-7; (1996 April)).

[0006] Acute symptoms of GERD include heartburn, pulmonary disorders andchest pain. On a chronic basis, GERD subjects the esophagus to ulcerformation, or esophagitis and may result in more severe complicationsincluding esophageal obstruction, significant blood loss and perforationof the esophagus. Severe esophageal ulcerations occur in 20-30% ofpatients over age 65. Moreover, GERD causes adenocarcinoma, or cancer ofthe esophagus, which is increasing in incidence faster than any othercancer (Reynolds J C: Influence Of Pathophysiology, Severity, And CostOn The Medical Management Of Gastroesophageal Reflux Disease. Am JHealth Syst Pharm, 53(22 Suppl 3):S5-12 (Nov. 15, 1996)).

[0007] Current drug therapy for GERD includes histamine receptorblockers which reduce stomach acid secretion and other drugs which maycompletely block stomach acid. However, while pharmacologic agents mayprovide short term relief, they do not address the underlying cause ofLES dysfunction.

[0008] Invasive procedures requiring percutaneous introduction ofinstrumentation into the abdomen exist for the surgical correction ofGERD. One such procedure, Nissen fundoplication, involves constructing anew “valve” to support the LES by wrapping the gastric fundus around thelower esophagus. Although the operation has a high rate of success, itis an open abdominal procedure with the usual risks of abdominal surgeryincluding: postoperative infection, herniation at the operative site,internal hemorrhage and perforation of the esophagus or of the cardia.In fact, a recent 10 year, 344 patient study reported the morbidity ratefor this procedure to be 17% and mortality 1% (Urschel, J D:Complications Of Antireflux Surgery, Am J Surg 166(1): 68-70; (1993July)). This rate of complication drives up both medical cost andconvalescence period for the procedure and may exclude portions ofcertain patient populations (e.g., the elderly and immuno-compromised).

[0009] Efforts to perform Nissen fundoplication by less invasivetechniques have resulted in the development of laparoscopic Nissenfundoplication. Laparoscopic Nissen fundoplication, reported byDallemagne et al. Surgical Laparoscopy and Endoscopy, Vol. 1, No. 3,(1991), pp. 138-43 and by Hindler et al. Surgical Laparoscopy andEndoscopy, Vol. 2, No. 3, (1992), pp. 265-272, involves essentially thesame steps as Nissen fundoplication with the exception that surgicalmanipulation is performed through a plurality of surgical cannulaintroduced using trocars inserted at various positions in the abdomen.

[0010] Another attempt to perform fundoplication by a less invasivetechnique is reported in U.S. Pat. No. 5,088,979. In this procedure, aninvagination device containing a plurality of needles is insertedtransorally into the esophagus with the needles in a retracted position.The needles are extended to engage the esophagus and fold the attachedesophagus beyond the gastroesophageal junction. A remotely operatedstapling device, introduced percutaneously through an operating channelin the stomach wall, is actuated to fasten the invaginatedgastroesophageal junction to the surrounding involuted stomach wall.

[0011] Yet another attempt to perform fundoplication by a less invasivetechnique is reported in U.S. Pat. No. 5,676,674. In this procedure,invagination is done by a jaw-like device and fastening of theinvaginated gastroesophageal junction to the fundus of the stomach isdone via a transoral approach using a remotely operated fasteningdevice, eliminating the need for an abdominal incision. However, thisprocedure is still traumatic to the LES and presents the postoperativerisks of gastroesophageal leaks, infection and foreign body reaction,the latter two sequela resulting when foreign materials such as surgicalstaples are implanted in the body.

[0012] While the methods reported above are less invasive than an openNissen fundoplication, some still involve making an incision into theabdomen and hence the increased morbidity and mortality risks andconvalescence period associated with abdominal surgery. Others incur theincreased risk of infection associated with placing foreign materialsinto the body. All involve trauma to LES and the risk of leaksdeveloping at the newly created gastroesophageal junction.

[0013] There is a need in the art for a less invasive GERD treatmentapparatus that does not require major surgical intervention or requirethe introduction of foreign materials into the body. Yet another needexists for a method of treating GERD that does not involve the medicalrisks of leakage and infection developing at an artificially createdgastroesophageal junction. Yet another need exists for an apparatus thattreats GERD with minimum trauma to the LES.

SUMMARY OF THE INVENTION

[0014] Accordingly, an object of the invention is to provide anapparatus and method for the treatment of GERD.

[0015] Another object of the invention is to provide an apparatus andmethod to treat GERD using minimally invasive surgical methods such asnon-percutaneous methods.

[0016] Yet another object of the invention is to provide an apparatusand method to treat the esophageal sphincters using minimally invasivesurgical methods.

[0017] Another object of the invention is to provide an apparatus andmethod to tighten the LES.

[0018] A further other object of the invention is to provide anapparatus and method to reduce the frequency of spontaneous relaxationand opening of the LES.

[0019] Yet another object of the invention is to provide an apparatusand method to reduce the frequency and severity of gastroesophagealreflux events.

[0020] These and other objects of the invention are provided in anapparatus with an expandable member sized to be positionable in asphincter. The energy delivery device is coupled to the expandablemember and has a configuration that controllably produces lesions of asufficient size, number and configuration in a sphincter so as to createa selectable tightening of the sphincter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0021]FIG. 1 is an illustrated lateral view of the upper GI tractincluding the esophagus and lower esophageal sphincter and thepositioning of the GERD treatment apparatus of the present invention thelower esophageal sphincter.

[0022]FIG. 2 is a lateral view of the present illustrating apertures inthe expandable member.

[0023]FIG. 3 illustrates a lateral view of an embodiment of theinvention that includes two expandable members and an electrode coupledto a power source.

[0024]FIG. 4 illustrates a lateral view of a proximal fitting and distalsegments of an embodiment of the invention.

[0025]FIG. 5 illustrates a lateral view of the deflection mechanism ofthe invention.

[0026]FIG. 6A illustrates a lateral view of apertures in the expandablemember and conforming member of the invention.

[0027]FIG. 6B illustrates a lateral view of a microporous membrane usedin the fabrication of the expandable member and conforming members ofthe invention.

[0028]FIG. 7 is a lateral view illustrating the use of the deflectionmechanism to deflect the expandable member of the present invention.

[0029]FIG. 8 is a lateral view illustrating the use of electrolyticsolution to create an enhanced RF electrode.

[0030]FIG. 9A is a lateral view illustrating a radial distribution ofelectrodes on the expandable member of the invention.

[0031]FIG. 9B is a lateral view illustrating a longitudinal distributionof electrodes on the expandable member of the invention.

[0032]FIG. 9C is a lateral view illustrating a spiral distribution ofelectrodes on the expandable member of the invention.

[0033]FIG. 10 is a lateral view illustrating the placement of electrodeson the distal segment of an embodiment the invention.

[0034]FIG. 11 is a lateral view illustrating the placement of needleelectrodes on the expandable member of an embodiment the invention.

[0035]FIG. 12 is a lateral view illustrating the deployment of needleelectrodes into the smooth muscle of the LES.

[0036]FIG. 13 is a lateral view illustrating the position of needleelectrodes in the distal segment of the expandable member.

[0037]FIG. 14 is a flow chart illustrating the GERD treatment method ofthe current invention.

[0038] FIGS. 15A-C are lateral views which illustrate a technique forproper positioning of the GERD treatment apparatus in the LES.

[0039]FIG. 16 is a lateral view of sphincter smooth muscle tissueillustrating electromagnetic foci and pathways for the origination andconduction of aberrant electrical signals in the smooth muscle of thelower esophageal sphincter.

[0040]FIG. 17 is a lateral view illustrating a zone of electrodes of thecurrent invention that comprises a flexible circuit that facilitatescontact with the lower esophageal sphincter.

[0041]FIG. 18 is a lateral view of the esophageal wall illustrating theinfiltration of tissue healing cells into a lesion in the smooth tissueof a esophageal sphincter following treatment with the GERD treatmentapparatus of the present invention.

[0042]FIG. 19 is a view similar to that of FIG. 18 illustratingshrinkage of the lesion site caused by cell infiltration.

[0043]FIG. 20 is a lateral view of the esophageal wall illustrating thepreferred placement of lesions in the smooth muscle layer of aesophageal sphincter.

[0044]FIG. 21 is a lateral view illustrating the creation of zones ofdecreased porosity by sealed conforming members of an embodiment of thepresent invention.

[0045]FIG. 22 is a lateral view illustrating the ultrasound transducer,ultrasound lens and ultrasound power source of an embodiment of thepresent invention.

[0046]FIG. 23 is a lateral view of the esophageal wall illustratingvarious patterns of lesions created by the apparatus of the presentinvention.

[0047]FIG. 24 is a lateral view of the esophageal wall illustrating thedelivery of cooling fluid to the electrode-tissue interface and thecreation of cooling zones.

[0048]FIG. 25 depicts the flow path, fluid connections and control unitemployed to deliver fluid to the electrode-tissue interface andelectrodes.

[0049]FIG. 26 is a lateral view illustrating the placement of coolingapertures adjacent to electrodes in the expandable member.

[0050]FIG. 27 depicts the flow path, fluid connections and control unitemployed to deliver fluid to the RF electrodes.

[0051]FIG. 28 is an enlarged lateral view illustrating the placement ofsensors on the expandable member.

[0052]FIG. 29 depicts a block diagram of the feed back control systemthat can be used with the GERD treatment apparatus as shown in FIG. 3.

[0053]FIG. 30 depicts a block diagram of an analog amplifier, analogmultiplexer and microprocessor used with the feedback control system ofFIG. 29.

[0054]FIG. 31 depicts a block diagram of the operations performed in thefeedback control system depicted in FIG. 29.

DETAILED DESCRIPTION

[0055] Referring now to FIGS. 1 and 2, one embodiment of GERD treatmentapparatus 10 that is used to deliver energy to a treatment site 12 toproduce lesions 14 in the LES includes a first expandable member 16 withan interior surface 18 and an exterior surface 20. First expandablemember 16, which can also be an energy delivery device support member,is configured to receive an expansion medium 22 that inflates firstexpandable member 16 from a compacted, non-deployed state to a deployedstate. Exterior surface 20 includes a plurality of apertures 24. Uponthe application of sufficient pressure, first expandable member 16 weepsexpansion medium 22 from interior surface 18.

[0056] While expandable member 16, with a single interior surface 18, ispreferred, it will be appreciated that expandable member 16 can be madeof different compositions or materials, with one or more open or closedcells or chambers. The plurality of such cells or chambers can becompressed or configured in a small diameter for insertion, and are thenexpanded after insertion to establish the desired electrical contactwith the targeted surface of the esophagus.

[0057] Expansion medium 22 may be a gas, fluid or the like. In variousembodiments, the expansion medium 22 can be an electrolytic solution. Inother embodiments, expansion medium 22 can also be a contrast solutionto facilitate imaging of the procedure by fluoroscopy orultrasonography. Yet in other embodiments, GERD treatment apparatus 10can include visualization capability including, but not limited to aviewing scope, ultrasound, an expanded eyepiece, fiber optics (includingillumination and imaging fibers), video imaging, a light source and thelike.

[0058] Referring to FIG. 3, a second expandable member 26 can bepositioned at least partially adjacent to first expandable member 16.Second expandable member 26 receives at least a portion of the expansionmedium 22 from interior surface 18.

[0059] An electromagnetic energy delivery device 28 is coupled to one ofthe first or second expandable members 16 and 26, respectively, andconfigured to be coupled to a power source 30.

[0060] First and second expandable members 16 and 26 are sized to beexpanded to sufficiently dilate the esophagus such that all or a portionof the interior of the lower esophageal sphincter can be accessible tothe energy delivery device 28. Expandable members 16 or 26 can dilatethe esophageal sphincter in a range of 5-40 mms. It will be appreciatedthat other devices capable of being in confined non-deployed states,during their introduction into the esophagus and thereafter expanded todeployed states at or near the LES, can be utilized. Such devicesinclude, but are not limited to, basket-shaped devices made ofsuperelastic metals such as nitinol.

[0061] Referring to FIG. 4, an extension member 32 with a distal segment34 is configured to be coupled to first and/or second expandable members16 and 26. In one embodiment, extension member 32 is rod-like and can bemalleable, flexible, articulated and steerable. In various embodiments,extension member 32 can contain optics, fluid and gas paths, sensor andelectronic cabling. In one embodiment, extension member 32 can be acoil-reinforced multilumen catheter, as is well known to those skilledin the art. Extension member 32 has sufficient length to position thefirst and second expandable members in the LES and/or stomach using atrans-oral approach. Typical lengths include, but are not limited to, arange of 40-180 cms. A proximal fitting 36 of extension member 32 ismaneuverable by a medical practitioner. In one embodiment, extensionmember 32 runs through the center of expandable member 16 and/or 26 anddistal segment 34 that extends distally beyond the most distalexpandable member. Extension member 32 may be attached to a movableproximal fitting 36 used to control deflection of expandable members 16or 26, as is more fully explained herein.

[0062] Referring to FIG. 5, expandable members 16 and 26 may beinitially rolled or folded around extension member 32. Expandablemembers 16 and 26 can be attached to a deflection mechanism 38, whichimparts movement of first and second expandable members 16 and 26 whenpositioned at the LES. In one embodiment, the deflection mechanism canbe a pull wire attached to extension member 32 or first expandablemember 16 and to a movable proximal fitting 36, as is well known tothose skilled in the art.

[0063] Formed spring wires can be included in first expandable member 16to assist in opening it to the deployed position. Optionally positionedproximal fitting 36 contains a variety of actuators which provide aphysician control of GERD treatment apparatus 10, as more fullydescribed hereafter. The actuators can be rocker switches, sliderswitches and the like, as are well known to those skilled in the art. Atleast portions of GERD treatment apparatus 10 may be sufficientlyradiopaque in order to be visible under fluoroscopy and/or sufficientlyechogenic to be visible under ultrasonography.

[0064] One embodiment of GERD treatment apparatus 10 is illustrated inFIG. 6A. First expandable member 16 is made of a material that can be aninsulator. For purposes of this disclosure, an insulator is a barrier tothermal or electrical energy flow. In this embodiment, expandable member16 is substantially surrounded by a conforming member 40 which is alsocalled a fluid conduit. Conforming member 40 receives electrolyticsolution from first expandable member 16, heated or not heated, througha plurality of apertures 24 formed in first expandable member 16, andpasses it to conforming member 40. In another embodiment, shown in FIG.6B, first expandable member 16 is made of a microporous material 42 thatdoes not include distinct apertures.

[0065] Referring to FIGS. 6A and 6B, conforming member 40 is made of amaterial that permits controlled delivery of the electrolytic solutionto the treatment site 12 through one or more apertures 24. In anotherembodiment, conforming member 40 can be made of microporous material 42that does not include distinct apertures. Extension member 32 with firstand second expandable members, or alternatively with a single expandablemember, is introduced into the esophagus directly, shown in FIG. 1, orthrough the use of another introducer such as an endoscope (not shown),as is more fully described hereafter with first and second expandablemembers 16 and 26 in non-deployed configurations.

[0066] Referring to FIG. 7, first expandable member 16 can be deflectedfrom side to side to facilitate maneuvering through the esophagus andpositioning in the LES. This movement can be imparted by deflectionmechanism 38.

[0067] A variety of energy sources can be coupled to the porous membraneincluding, (i) an RF source coupled to an RF electrode, (ii) a coherentsource of light coupled to an optical fiber, (iii) an incoherent lightsource coupled to an optical fiber, (iv) a heated fluid coupled to acatheter with an open channel configured to receive the heated fluid,(v) a heated fluid coupled to a catheter with an open channel configuredto receive the heated fluid, (vi) a cooled fluid coupled to a catheterwith a closed channel configured to receive the cooled fluid, (vii) acooled fluid coupled to a catheter with an open channel configured toreceive the cooled fluid, (viii) a cryogenic fluid, (ix) a resistiveheating source, (x) a microwave source providing energy from 915 MHz to2.45 GHz and coupled to a microwave antenna, (xi) an ultrasound powersource coupled to an ultrasound emitter, wherein the ultrasound powersource produces energy in the range of 300 KHZ to 3 GHz or (xii) amicrowave source. For ease of discussion for the remainder of thisapplication, the energy source utilized is an RF source andelectromagnetic energy delivery device 28 is a single or a plurality ofRF electrodes 44, also described as electrodes 44. However, all of theother mentioned energy sources are equally applicable to GERD treatmentapparatus 10.

[0068] For the case of RF energy, RF electrode 44 may operated in eitherbipolar or monopolar mode with a ground pad electrode. In a monopolarmode of delivering RF energy, a single electrode 44 is used incombination with an indifferent electrode patch that is applied to thebody to form the other contact and complete an electrical circuit.Bipolar operation is possible when two or more electrodes 44 are used.Multiple electrodes 44 may be used. Also, electrolytic solution servesas an enhanced RF electrode 44′ when coupled with an RF electrode 44(refer to FIG. 8).

[0069] Also when the energy source is RF, power source 30, which willnow be referred to as a RF energy source 30, may have multiple channels,delivering separately modulated power to each electrode 44. This reducespreferential heating that occurs when more energy is delivered to a zoneof greater conductivity and less heating occurs around electrodes 44which are placed into less conductive tissue. If the tissue hydration orthe blood infusion in the tissue is uniform, a single channel RF energysource 30 may be used to provide power for generation of lesions 14relatively uniform in size.

[0070] Electric current flowing through targeted smooth muscle tissuecauses heating due to resistance of the tissue resulting in injury tothe tissue which can be sufficient to cause the death of affected cells,also known as necrosis. For ease of discussion for the remainder of thisapplication, cell injury will include all cellular effects resultingfrom the delivery of energy from the electrode 44 up to and includingcell necrosis. Cell injury can be accomplished as a relatively simplemedical procedure with local anesthesia. In one embodiment, cell injuryproceeds to a depth of approximately 1-4 mms from the surface of themucosal layer.

[0071] Referring now to FIGS. 9A-C, electrodes 44 can cover all or aportion of expandable members 16 or 26 and/or conforming member 40.Also, electrodes 44 may be distributed in a variety of patterns along anexterior or interior surface of either expandable member 16 or 26 orconforming member 40, in order to produce a desired placement andpattern of lesions 14. Typical electrode distribution patterns include,but are not limited, to a radial distribution 46 (refer to FIG. 9A) or alongitudinal distribution 48 (refer to FIG. 9B). It will be appreciatedthat other patterns and geometries for electrode placement, such as aspiral distribution 50 (refer to FIG. 9C) may also be suitable. In oneembodiment, electrode 44 is positioned on distal segment 34 of extensionmember 32 (refer to FIG. 10). These electrodes may be cooled asdescribed hereafter. Additionally, distal segment 34 may includeapertures 24 for delivery of cooling and electrolytic solution asdescribed hereafter.

[0072] Electrodes 44 can have a variety of shapes and sizes. Possibleshapes include but are not limited to circular, rectangular, conical andpyramoidal. Electrode surfaces can be smooth or textured and concave orconvex. Surface areas can range from 0.1 mm² to 200 mm². It will beappreciated that other geometries and surface areas may be equallysuitable. In one embodiment, electrodes 44 can be in the shape ofneedles and of sufficient sharpness and length to penetrate into thesmooth muscle of the esophageal wall. In this case, needle electrodes 52are attached to expandable member 16 or 26 which is located insideconforming member 40 (refer to FIG. 11). During introduction of the GERDtreatment apparatus 10 into the esophagus, needle electrodes 52 remainretracted inside conforming member 40. Once GERD treatment apparatus 10is properly positioned at the treatment site 12, needle electrodes 52are deployed by expansion of expandable member 16 or 26, resulting inprotrusion of needle electrodes 52 through needle apertures 54 inconforming member 40 and into the smooth muscle tissue of the treatmentsite 12 (refer to FIG. 12). In another embodiment, distal segment 34 mayalso contain needle apertures 54 for protrusion of needle electrodes 52into the smooth muscle of the esophageal wall. In this embodiment, shownin FIG. 13 needle electrodes 52 are coupled to an insulated guide wire56 (known to those skilled in the art) which is advanced through a guidewire lumen 58 in extension member 32.

[0073]FIG. 14 is a flow chart illustrating one embodiment of theoperation of GERD treatment apparatus 10. In this embodiment, GERDtreatment apparatus 10 is first introduced into the esophagus underlocal anesthesia. GERD treatment apparatus 10 can be introduced into theesophagus by itself or through a lumen in an endoscope, such asdisclosed in U.S. Pat. Nos. 5,448,990 and 5,275,608, incorporated hereinby reference, or similar esophageal access device known to those skilledin the art. Expandable member 16 or 26 is expanded with the introductionof a fluid or gaseous expansion medium 22, such as an electrolyticsolution, or a combination of both. This serves to temporarily dilatethe esophagus sufficiently to efface a portion of or all of the folds ofthe LES. In an alternative embodiment, esophageal dilation andsubsequent LES fold effacement can be accomplished by insufflation ofthe esophagus (a known technique) using gas introduced into theesophagus through a channel in the GERD treatment device, or anendoscope or similar esophageal access device as described above. Oncetreatment is completed, expandable members 16 or 26 are evacuated offluid or gas and returned to their predeployed state and GERD treatmentapparatus 10 is withdrawn from the esophagus. This results in the LESreturning to approximately its pretreatment state and diameter.

[0074] In one embodiment, electrolytic solution is introduced intoexpandable member 16 or 26, causing it to become distended and beself-retained in the esophagus. Expandable member 16 or 26 can also beexpanded mechanically through the use of formed spring wires (not shown)used alone or in combination with a fluid.

[0075] Electrolytic solution in expandable member 16 may be heated to atemperature, which can be modified and adjusted as necessary. Forexample, electrolytic solution can be heated and maintained at atemperature between about 65-90° C. It can be initially introduced intofirst expandable member 16 at the higher temperature, or it can beheated to the higher temperature in first expandable member 16. Byproviding a heated electrolytic solution, there is a reduction in theamount of time needed to complete a satisfactory degree of tissue injuryof targeted cells.

[0076] It is important to have proper positioning of the expandablemembers 16 and 26 and conforming member 40 in the sphincter during bothdiagnosis and treatment phases. This can be facilitated by the followingprocedure: (I) carefully advancing one or both of expandable members 16and 26 in an unexpanded state, distal to the lower esophageal sphincter,(ii) expanding the distal one of the two expandable members and (iii)carefully withdrawing GERD treatment apparatus 10 proximally untilresistance is encountered. This procedure is illustrated in FIGS. 15A-C.

[0077] The diagnostic phase then begins. This is achieved through avariety of diagnostic methods, including, but not limited to, thefollowing: (I) visualization of the interior surface of the esophagusvia an endoscope or other viewing apparatus inserted into the esophagus,(ii) visualization of the interior morphology of the esophageal wallusing ultrasonography to establish a baseline for the tissue to betreated, (iii) impedance measurement to determine the electricalconductivity between the esophageal mucosal layers and GERD treatmentapparatus 10 and (iv) measurement and surface mapping of theelectropotential of the LES during varying time periods which mayinclude such events as depolarization, contraction and repolarization ofLES smooth muscle tissue. This latter technique is done to determinespecific sites in the LES to be treated which are acting as foci 60 orpathways 62 for abnormal or inappropriate polarization and relaxation ofthe smooth muscle of the LES (Refer to FIG. 16).

[0078] In the treatment phase, the delivery of energy of the targetedsite can be conducted under feedback control, manually or a combinationof both. Feedback control enables GERD treatment apparatus 10 to bepositioned and retained in the esophagus during treatment with minimalattention by the physician. When positioned at the LES, GERD treatmentapparatus 10 provides a relatively even flow of heated electrolyticsolution to facilitate the cell injury process. As shown in FIG. 17,GERD treatment apparatus 10 also may have a plurality of electrodes 44contained in zones that effectively create a flexible circuit 64 whichin turn, facilitates contact of the electrode 44 with all or a portionof the interior surface areas of the LES. Electrodes 44 can bemultiplexed in order to treat the targeted site or only a portionthereof. Feedback can be included and is achieved by, (I) visualization,(ii) impedance measurement, (iii) ultrasonography, (iv) temperaturemeasurement; and, (v) sphincter contractile force measurement viamanometry. The feedback mechanism permits the selected on-off switchingof different electrodes 44 of the flexible circuit 64 in a desiredpattern, which can be sequential from one electrode 44 to an adjacentelectrode 44, or can jump around between non-adjacent electrodes 44.Individual electrodes 44 are multiplexed and volumetrically controlledby a controller.

[0079] The area and magnitude of cell injury in the LES can vary.However, it is desirable to deliver sufficient energy to the targetedtreatment site 12 to be able to achieve tissue temperatures in the rangeof 55-95° C. and produce lesions 14 at depths ranging from 1-4 mm fromthe interior surface of the LES. Typical energies delivered to theesophageal wall include, but are not limited to, a range between 100 and50,000 joules per electrode 44. It is also desirable to deliversufficient energy such that the resulting lesions 14 have a sufficientmagnitude and area of cell injury to cause an infiltration of lesion 14by fibroblasts 66, myofibroblasts 68, macrophages 70 and other cellsinvolved in the tissue healing process (refer to FIG. 18). As shown inFIGS. 19A and B, these cells cause a contraction of tissue around lesion14, decreasing its volume and, or altering the biomechanical propertiesat lesion 14 so as to result in a tightening of LES. These changes arereflected in transformed lesion 14′ shown in 19B. The diameter oflesions 14 can vary between 0.1 to 4 mm. It is preferable that lesions14 are less than 4 mm in diameter in order to reduce the risk of thermaldamage to the mucosal layer. In one embodiment, a 2 mm diameter lesion14 centered in the wall of the smooth muscle provides a 1 mm buffer zoneto prevent damage to the mucosa, submucosa and adventia, while stillallowing for cell infiltration and subsequent tightening onapproximately 50% of the thickness of the wall of the smooth muscle(refer to FIG. 20).

[0080] In one embodiment, GERD treatment apparatus 10 conforms tightlywith the interior of the esophagus so that all, or nearly all, of theinterior circumference of a desired segment of the LES is in contactwith a surface of conforming member 40. Conforming member 40 is fittedinto the entire LES and expandable member 16 does not have to be movedabout the esophagus to complete the treatment. Alternatively, GERDtreatment apparatus 10 may not entirely fill the esophagus, and GERDtreatment apparatus 10 is then moved about the esophagus in order totreat all of the esophagus, or those sections where tightening of thelower esophageal sphincter is desired.

[0081] Conforming member 40 is made of a material that substantiallyconforms to the surface of the LES and, or other sphincters. Thisprovides better conformity than the mere use of expandable member 16. Asa result, the delivery of treatment energy to the LES is enhanced.Energy delivery may also be enhanced by use of a conducting surface 72which may cover all, or part of, the exterior of conforming member 40.The surface of conforming member 40 can be made conductive by a varietyof means including, but not limited to chemical coating with aconductive material, implantation with conductive ions and applicationof a conductive film.

[0082] Conforming member 40 can have a thickness in the range of about0.01 to 2.0 cm. Conforming member 40 can be made of a foam typematerial. Suitable materials include, but are not limited to, knittedpolyester, continuous filament polyester, polyester-cellulose, rayon,polyamide, polyurethane, polyethylene, silicone, and the like. Suitablecommercial foams include, (i) Opcell, available from Sentinel ProductsCorp., Hyannis, Mass. and (ii) UltraSorb, HT 4201 or HT 4644MD fromWilshire Contamination Control, Carlsbad, Calif. Conforming member 40has characteristics that make it particularly moldable and formable toirregular surfaces. In one embodiment, conforming member 40 is made ofan open cell foam, or alternatively it can be a thermoplastic film suchas polyurethane, low density polyethylene, or it may be a silicone.Additionally, conforming member 40 can be capable of extrudingconductive materials from conforming member 40 itself.

[0083]FIG. 21 illustrates that conforming member 40 can be created bysealing two smaller conforming members 74 and 76 together. Smallerconforming members 74 and 76 are sealed together between individualelectrodes 44. This creates a pocket or zone 78. Zone 78 has a lowerporosity for the flow of electrolytic solution than non-zone sections80, e.g., all other sections of conforming member 40 which do notinclude a zone 78 with an associated electrode 44. The porosity ofnon-zone sections 80 is greater than the porosity of zones 78.

[0084] From a diagnostic standpoint, it is desirable to image theinterior surface 18 and wall of the LES including the size and positionof created lesions 14. It is desirable to create a map of thesestructures which can input to a controller and used to direct thedelivery of energy to the treatment site. Referring to FIG. 22, this canbe accomplished through the use of ultrasonography (a known procedure)which involves the use of an ultrasound power source 82 coupled to oneor more ultrasound transducers 84 that are positioned in or onexpandable member 16 or 26 or conforming member 40. An output isassociated with ultrasound power source 82 and RF energy source 30.

[0085] Each ultrasound transducer 84 can include a piezoelectric crystal86 mounted on a backing material 88 that is in turn attached toexpandable members 16 or 26 or conforming member 40. An ultrasound lens90, fabricated on an electrically insulating material 92, is mountedover the piezoelectric crystal 86 The piezoelectric crystal 86 isconnected by electrical leads 94 to ultrasound power source 82. Eachultrasound transducer 84 transmits ultrasound energy through conformingmember 40 or expandable members 16 or 26 into adjacent tissue.Ultrasound transducers 84 can be in the form of an imaging probe such asModel 21362, manufactured and sold by Hewlett Packard Company, PaloAlto, Calif. In one embodiment, two ultrasound transducers 84 arepositioned on opposite sides of expandable member 16 to create an imagedepicting the size and position of lesion 14 in the LES.

[0086] It is desirable that lesions 14 are predominantly located in thesmooth muscle layer of esophageal wall at the depths ranging from 1 to 4mms from the interior surface of the sphincter. However, lesions 14 canvary both in number and position within the sphincter wall. It may bedesirable to produce a pattern of multiple lesions 14 within theesophageal smooth muscle in order to obtain a selected degree oftightening of the LES. Typical lesion patterns shown in FIGS. 23A-Cinclude but are not limited to, (i) a concentric circle of lesions 14all at fixed depth in the smooth muscle layer evenly spaced along theradial axis of the LES, (ii) a wavy or folded circle of lesions 14 atvarying depths in the smooth muscle layer evenly spaced along the radialaxis of the LES, (iii) lesions 14 randomly distributed at varying depthsin the smooth muscle, but evenly spaced in a radial direction; and, (iv)an eccentric pattern of lesions 14 in one or more radial locations inthe smooth muscle wall. Accordingly, the depth of RF and thermal energypenetration in the lower esophageal sphincter is controlled andselectable. The selective application of energy to the lower esophagealsphincter may be the even penetration of RF energy to the entiretargeted site, a portion of it, or applying different amounts of RFenergy to different sites depending on the condition of the sphincter.If desired, the area of cell injury can be substantially the same forevery treatment event.

[0087] Referring to FIG. 24, it may be desirable to cool all or aportion of the area near the electrode-tissue interface 96 before duringand after the delivery of energy in order to reduce the degree and areaof cell injury. Specifically the use of cooling preserves the mucosallayers and protects or otherwise reduces the degree of cell damage tocooled zone 98 in the vicinity of the lesion 14. This can beaccomplished through the use of a cooling fluid 100 that weeps out ofthe expandable members 16 and 26 or conforming member 40 which is influid communication with a continuous lumen 102 in extension member 32that is, in turn, in fluid communication with fluid reservoir 104 and acontrol unit 106, whose operation will be described hereafter thatcontrols the delivery of the fluid (Refer to FIG. 25). All or only aportion of electrode 44 may also be cooled.

[0088] Similarly, it may also be desirable to cool all or a portion ofthe electrode 44. The rapid delivery of heat through electrode 44, mayresult in the build up of charred biological matter on electrode 44(from contact with tissue and fluids e.g. blood) that impedes the flowof both thermal and electrical energy from electrode 44 to adjacenttissue and causes an electrical impedance rise beyond a cutoff value seton RF energy source 30. A similar situation may result from thedesiccation of tissue adjacent to electrode 44. Cooling of the electrode44 can be accomplished by cooling fluid 100 that weeps out of expandablemembers 16 and/or 26 and conforming member 40 as described previously.In another embodiment, expandable member 16 may contain a plurality ofcooling apertures 108 adjacent or directed toward electrode 44 toenhance the flow of cooling solution and, or cooling rate of electrode44 and adjacent tissue (refer to FIG. 26). Referring now to FIG. 27,electrode 44 may also be cooled via a fluid channel 110 in electrode 44that is in fluid communication with fluid reservoir 104 and control unit106 via the continuous lumen 102 in extension member 32 as describedpreviously.

[0089] As shown in FIG. 28, one or more sensors 112 may be positionedadjacent or on electrode 44 for sensing the temperature of esophagealtissue at treatment site 12. More specifically, sensors 112 permitaccurate determination of the surface temperature of the esophagus atelectrode-tissue interface 96. This information can be used to regulateboth the delivery of energy and cooling solution to the interior surfaceof the esophagus. In various embodiments sensors 112 can be positionedat any position on expandable members 16 and 26 and conforming member40. Suitable sensors that may be used for sensor 112 include:thermocouples, fiber optics, resistive wires, thermocouple IR detectors,and the like. Suitable thermocouples for sensor 112 include: T type withcopper constantene, J type, E type and K types as are well known thoseskilled in the art.

[0090] Temperature data from sensors 112 are fed back to control unit106 and through an algorithm which is stored within a microprocessormemory of control unit 106. Instructions are sent to an electronicallycontrolled micropump (not shown) to deliver fluid through the fluidlines at the appropriate flow rate and duration to provide controltemperature at the electrode-tissue interface 96 (refer to FIG. 28).

[0091] The reservoir of control unit 106 may have the ability to controlthe temperature of the cooling fluid 100 by either cooling the fluid orheating the fluid. Alternatively, a fluid reservoir 104 of sufficientsize may be used in which the cooling fluid 100 is introduced at atemperature at or near that of the normal body temperature. Using athermally insulated reservoir 114, adequate control of the tissuetemperature may be accomplished without need of refrigeration or heatingof the cooling fluid 100. Cooling fluid 100 flow is controlled bycontrol unit 106 or another feedback control system (described herein)to provide temperature control at the electrode-tissue interface 96.

[0092] A second diagnostic phase may be included after the treatment iscompleted. This provides an indication of lower esophageal tighteningtreatment success, and whether or not a second phase of treatment, toall or only a portion of the esophagus, now or at some later time,should be conducted. The second diagnostic phase is accomplishedthrough, (I) visualization, (ii) measuring impedance, (iii)ultrasonography or (iv) temperature measurement, (v) measurement of LEStension and contractile force via manometry.

[0093] In one embodiment, GERD treatment apparatus 10 is coupled to anopen or closed loop feedback system. Referring now to FIG. 29, an openor closed loop feedback system couples sensor 346 to energy source 392.In this embodiment, RF electrode 314 is one or more RF electrodes 314.

[0094] The temperature of the tissue, or of RF electrode 314 ismonitored, and the output power of energy source 392 adjustedaccordingly. The physician can, if desired, override the closed or openloop system. A microprocessor can be included and incorporated in theclosed or open loop system to switch power on and off, as well asmodulate the power. The closed loop system utilizes a microprocessor 394to serve as a controller, monitor the temperature, adjust the RF power,analyze at the result, refeed the result, and then modulate the power.

[0095] With the use of sensor 346 and the feedback control system atissue adjacent to RF electrode 314 can be maintained at a desiredtemperature for a selected period of time without impeding out. Each RFelectrode 314 is connected to resources which generate an independentoutput. The output maintains a selected energy at RF electrode 314 for aselected length of time.

[0096] Current delivered through RF electrode 314 is measured by currentsensor 396. Voltage is measured by voltage sensor 398. Impedance andpower are then calculated at power and impedance calculation device 400.These values can then be displayed at user interface and display 402.Signals representative of power and impedance values are received by acontroller 404.

[0097] A control signal is generated by controller 404 that isproportional to the difference between an actual measured value, and adesired value. The control signal is used by power circuits 406 toadjust the power output in an appropriate amount in order to maintainthe desired power delivered at respective RF electrodes 314.

[0098] In a similar manner, temperatures detected at sensor 346 providefeedback for maintaining a selected power. Temperature at sensor 346 isused as a safety means to interrupt the delivery of energy when maximumpre-set temperatures are exceeded. The actual temperatures are measuredat temperature measurement device 408, and the temperatures aredisplayed at user interface and display 402. A control signal isgenerated by controller 404 that is proportional to the differencebetween an actual measured temperature and a desired temperature. Thecontrol signal is used by power circuits 406 to adjust the power outputin an appropriate amount in order to maintain the desired temperaturedelivered at the sensor 346. A multiplexer can be included to measurecurrent, voltage and temperature, at the sensor 346, and energy can bedelivered to RF electrode 314 in monopolar or bipolar fashion.

[0099] Controller 404 can be a digital or analog controller, or acomputer with software. When controller 404 is a computer it can includea CPU coupled through a system bus. On this system can be a keyboard, adisk drive, or other non-volatile memory systems, a display, and otherperipherals, as are known in the art. Also coupled to the bus is aprogram memory and a data memory.

[0100] User interface and display 402 includes operator controls and adisplay. Controller 404 can be coupled to imaging systems, including butnot limited to ultrasound, CT scanners, X-ray, MRI, mammographic X-rayand the like. Further, direct visualization and tactile imaging can beutilized.

[0101] The output of current sensor 396 and voltage sensor 398 is usedby controller 404 to maintain a selected power level at RF electrode314. The amount of RF energy delivered controls the amount of power. Aprofile of power delivered can be incorporated in controller 404 and apreset amount of energy to be delivered may also be profiled.

[0102] Circuitry, software and feedback to controller 404 result inprocess control, and the maintenance of the selected power setting thatis independent of changes in voltage or current, and used to change, (i)the selected power setting, (ii) the duty cycle (on-off time), (iii)bipolar or monopolar energy delivery and (iv) fluid delivery, includingflow rate and pressure. These process variables are controlled andvaried, while maintaining the desired delivery of power independent ofchanges in voltage or current, based on temperatures monitored at sensor346.

[0103] As illustrated in FIG. 30, current sensor 396 and voltage sensor398 are connected to the input of an analog amplifier 410. Analogamplifier 410 can be a conventional differential amplifier circuit foruse with sensor 346. The output of analog amplifier 410 is sequentiallyconnected by an analog multiplexer 412 to the input of A/D converter414. The output of analog amplifier 410 is a voltage which representsthe respective sensed temperatures. Digitized amplifier output voltagesare supplied by A/D converter 414 to microprocessor 394. Microprocessor394 may be a type 68HCII available from Motorola. However, it will beappreciated that any suitable microprocessor or general purpose digitalor analog computer can be used to calculate impedance or temperature.

[0104] Microprocessor 394 sequentially receives and stores digitalrepresentations of impedance and temperature. Each digital valuereceived by microprocessor 394 corresponds to different temperatures andimpedances.

[0105] Calculated power and impedance values can be indicated on userinterface and display 402. Alternatively, or in addition to thenumerical indication of power or impedance, calculated impedance andpower values can be compared by microprocessor 394 with power andimpedance limits. When the values exceed predetermined power orimpedance values, a warning can be given on user interface and display402, and additionally, the delivery of RF energy can be reduced,modified or interrupted. A control signal from microprocessor 394 canmodify the power level supplied by energy source 392.

[0106]FIG. 31 illustrates a block diagram of a temperature/impedancefeedback system that can be used to control the flow rate and durationof cooling fluid 100 through continuous lumen 102 to expandable andconforming members 16, 26 and 40 and or RF electrode 314. Energy isdelivered to RF electrode 314 by energy source 392, and applied totissue site 424. A monitor 416 ascertains tissue impedance, based on theenergy delivered to tissue, and compares the measured impedance value toa set value. If the measured impedance exceeds the set value, adisabling signal 418 is transmitted to energy source 392, ceasingfurther delivery of energy to RF electrode 314. If measured impedance iswithin acceptable limits, energy continues to be applied to the tissue.During the application of energy sensor 346 measures the temperature oftissue and/or RF electrode 314. A comparator 420 receives a signalrepresentative of the measured temperature and compares this value to apre-set signal representative of the desired temperature. Comparator 420sends a signal to a flow regulator 422 connected to an electronicallycontrolled micropump (not shown) representing a need for an increasedcooling fluid 100 flow rate, if the tissue temperature is too high, orto maintain the flow rate if the temperature has not exceeded thedesired temperature.

[0107] The foregoing description of a preferred embodiment of theinvention has been presented for purposes of illustration anddescription. It is not intended to be exhaustive or to limit theinvention to the precise forms disclosed. Obviously, many modificationsand variations will be apparent to practitioners skilled in this art. Itis intended that the scope of the invention be defined by the followingclaims and their equivalents.

What is claimed is:
 1. An apparatus, comprising: an expandable memberbeing sized to be positionable in a sphincter; and an energy deliverydevice coupled to the expandable member, the energy delivery devicehaving a configuration that controllably produces lesions of asufficient size, number and configuration in an interior of thesphincter so as to create a selectable tightening of the sphincter. 2.The apparatus of claim 1, wherein the configuration of the energydelivery device includes a plurality of energy delivery membersdistributed on a surface of the expandable member.
 3. The apparatus ofclaim 2, wherein the plurality of energy delivery members are radiallydistributed along a surface of the energy delivery device expandablemember.
 4. The apparatus of claim 2, wherein the plurality of energydelivery members are longitudinally distributed along a surface of theexpandable member.
 5. The apparatus of claim 1, wherein the energydelivery device covers a portion of the surface of the expandablemember.
 6. The apparatus of claim 2, wherein the energy delivery devicecovers substantially all of an exterior surface of the expandablemember.
 7. The apparatus of claim 1, wherein the expandable member issized to be positionable in a sphincter and to allow the energy deliverydevice to contact a portion of the inner surface of a sphincter.
 8. Theapparatus of claim 1, wherein the expandable member is sized to bepositionable in a sphincter and to allow the energy delivery device tocontact all of an inner surface of the sphincter.
 9. The apparatus ofclaim 1, where the energy delivery device is sized to be positionable inthe sphincter and non-permanently dilate the sphincter from a contractedstate; and wherein the sphincter returns to a pretreatment contractedstate upon a removal of the expandable member from the sphincter. 10.The apparatus of claim 1, wherein the lesions are formed in a muscletissue underlying a sphincter mucosal layer.
 11. The apparatus of claim1, wherein the sphincter is a lower esophageal sphincter.
 12. Theapparatus of claim 1, wherein the configuration of the energy deliverydevice creates the lesions at a fixed depth from a mucosal surface layerof the sphincter of no more than 4 mms.
 13. The apparatus of claim 1,wherein the configuration of the energy delivery device creates thelesions and minimizes injury to a mucosal and a submucosal layer of thesphincter.
 14. The apparatus of claim 1, wherein the configuration ofthe energy delivery device creates the lesions and reduces a frequencyof sphincter relaxation.
 15. The apparatus of claim 1, wherein theconfiguration of the energy delivery device creates the lesions andreduces a duration of sphincter relaxation.
 16. The apparatus of claim1, wherein the configuration of the energy delivery device creates thelesions and reduces a frequency of reflux of stomach contents into anesophagus.
 17. The apparatus of claim 1, wherein the configuration ofthe energy delivery device creates the lesions and reduces a frequencyof a symptom of reflux of stomach contents into an esophagus.
 18. Theapparatus of claim 1, wherein the configuration of the energy deliverydevice creates the lesions and reduces an incidence of a sequela ofreflux of stomach contents into an esophagus.
 19. The apparatus of claim1, wherein the energy delivery device is positioned on an exteriorsurface of the expandable member.
 20. The apparatus of claim 1, whereinthe energy delivery device is positioned on an interior surface of theexpandable member.
 21. The apparatus of claim 1, further comprising: alumen positioned in an interior of the expandable member.
 22. Theapparatus of claim 1, wherein the expandable member is expandable. 23.The apparatus of claim 1, wherein the expandable member is a balloon.24. The apparatus of claim 1, wherein the expandable member is made ofan expandable material.
 25. The apparatus of claim 1, wherein theexpandable member is made of a porous material.
 26. The apparatus ofclaim 1, further comprising: an electrolytic solution housed in anexpanded expandable member.
 27. The apparatus of claim 1, wherein theconfiguration of the energy delivery device delivers energy to promote afibroblast cell infiltration at a site of the lesions.
 28. The apparatusof claim 1, wherein the configuration of the energy delivery devicedelivers energy to promote a fibroblast growth at a site of the lesions.29. The apparatus of claim 1, wherein the configuration of the energydelivery device delivers energy that promotes a mylofibroblast cellinfiltration at a site of the lesions.
 30. The apparatus of claim 1,wherein the configuration of the energy delivery device creates atightening of a lower esophageal sphincter without permanently damaginganatomical structures near the lower esophageal sphincter.
 31. Theapparatus of claim 1, wherein the configuration of the energy deliverydevice creates a tightening of the lower esophageal sphincter withoutpermanently damaging an aorta positioned near the lower esophagealsphincter.
 32. The apparatus of claim 1, wherein the configuration ofthe energy delivery device creates a tightening of the lower esophagealsphincter without permanently damaging a vagus nerve positioned near thelower esophageal sphincter.
 33. The apparatus of claim 1, wherein theconfiguration of the energy delivery device creates a tightening of thelower esophageal sphincter without permanently damaging an esophagealplexus of nerves and veins positioned near the lower esophagealsphincter.
 34. The apparatus of claim 1, wherein the configuration ofthe energy delivery device creates a tightening of the lower esophagealsphincter while preserving a blood supply to the lower esophagealsphincter.
 35. The apparatus of claim 1, wherein the energy deliverydevice is an RF electrode.
 36. The apparatus of claim 35, furthercomprising: an RF energy source coupled to the RF electrode.
 37. Theapparatus of claim 1, wherein the energy delivery device is a microwaveantenna.
 38. The apparatus of claim 37, further comprising: a microwaveenergy source coupled to the microwave antenna.
 39. The apparatus ofclaim 1, wherein the energy delivery device is a waveguide.
 40. Theapparatus of claim 39, further comprising: a light source coupled to thewaveguide.
 41. The apparatus of claim 40, wherein the light source is alaser.
 42. The apparatus of claim 1, wherein the energy delivery deviceis an acoustical transducer.
 43. The apparatus of claim 1, wherein theenergy delivery device is a resistive heating device.
 44. The apparatusof claim 1, further comprising: a visualization device coupled to theexpandable member.
 45. The apparatus of claim 1, further comprising: anextension member coupled to the expandable member.
 46. The apparatus ofclaim 45, wherein a proximal portion of the extension member ismaneuverable by a medical practioner.
 47. The apparatus of claim 1,wherein the energy delivery device is a plurality of RF electrodes. 48.The apparatus of claim 47, wherein the plurality of electrodes is aflexible circuit.
 49. The apparatus of claim 1, further comprising: amechanical expansion device coupled to the expandable member.
 50. Anapparatus, comprising: an expandable member means sized to bepositionable in a lower esophageal sphincter and non-permanently dilatethe lower esophageal sphincter from a contracted state; an energydelivery device means coupled to the expandable member means, the energydelivery device means having a configuration that controllably produceslesions of a sufficient size, number and configuration in an interior ofthe lower esophageal sphincter to create a tightening of the loweresophageal sphincter; and, wherein the lower esophageal sphincterreturns to a contracted state upon a removal of the expandable membermeans from the sphincter.
 51. The apparatus of claim 50, wherein theenergy delivery device means has a configuration that controllablyproduces lesions an interior of the lower esophageal sphincter withoutcreating a permanent impairment of the lower esophageal sphincter'sability to achieve a physiologically normal state of closure.
 52. Theapparatus of claim 50, wherein the energy delivery device is positionedon an exterior surface of the expandable member means.
 53. The apparatusof claim 50, wherein the energy delivery device is positioned on aninterior surface of the expandable member means.
 54. The apparatus ofclaim 50, further comprising: a lumen means positioned in an interior ofthe expandable member means.
 55. The apparatus of claim 50, wherein theexpandable member means is expandable.
 56. The apparatus of claim 50,wherein the expandable member means is a balloon.
 57. The apparatus ofclaim 50, wherein the expandable member means is made of an expandablematerial.
 58. The apparatus of claim 50, wherein the expandable membermeans is made of a porous material.
 59. The apparatus of claim 57,further comprising: an electrolytic solution means housed in an expandedexpandable member means.
 60. The apparatus of claim 50, wherein theconfiguration of the energy delivery device means delivers energy to theinterior of the lower esophageal sphincter and creates a fibroblastproliferation in the interior of the lower esophageal sphincter.
 61. Theapparatus of claim 50, wherein the configuration of the energy deliverydevice means delivers energy to the interior of the lower esophagealsphincter and creates a myofibroblast proliferation in the loweresophageal sphincter.
 62. The apparatus of claim 50, wherein theconfiguration of the energy delivery device means creates a tighteningof the lower esophageal sphincter without permanently disrupting anaorta positioned near the lower esophageal sphincter.
 63. The apparatusof claim 50, wherein the configuration of the energy delivery devicemeans creates a tightening of the lower esophageal sphincter withoutpermanently damaging a vagus nerve positioned near the lower esophagealsphincter.
 64. The apparatus of claim 50, wherein the configuration ofthe energy delivery device means creates a tightening of the loweresophageal sphincter without permanently damaging an esophageal plexusof nerves and veins positioned near the lower esophageal sphincter. 65.The apparatus of claim 50, wherein the configuration of the energydelivery device means creates a tightening of the lower esophagealsphincter while preserving a blood supply to the lower esophagealsphincter.
 66. The apparatus of claim 50, wherein the configuration ofthe energy delivery device means creates a tightening of the loweresophageal sphincter while creating submucosal lesions in the loweresophageal sphincter.
 67. The apparatus of claim 50, wherein the energydelivery device means is an RE electrode means.
 68. The apparatus ofclaim 47, further comprising: an RF energy source means coupled to theRF electrode means.
 69. The apparatus of claim 50, wherein the energydelivery device means is a microwave antenna means.
 70. The apparatus ofclaim 69, further comprising: a microwave energy source means coupled tothe microwave antenna means.
 71. The apparatus of claim 50, wherein theenergy delivery device means is a waveguide means.
 72. The apparatus ofclaim 71, further comprising: a light source means coupled to thewaveguide means.
 73. The apparatus of claim 72, wherein the light sourcemeans is a laser means.
 74. The apparatus of claim 50, wherein theenergy delivery device means is an acoustical transducer means.
 75. Theapparatus of claim 74, further comprising: an acoustical energy sourcemeans coupled to the acoustical transducer means.
 76. The apparatus ofclaim 50, wherein the energy delivery device means is a resistiveheating device means.
 77. The apparatus of claim 50, further comprising:a visualization device means coupled to the expandable member means. 78.The apparatus of claim 50, further comprising: a extension member meanscoupled to the expandable member means.
 79. The apparatus of claim 78,wherein a proximal portion of the extension member means is maneuverableby a medical practioner.
 80. The apparatus of claim 50, wherein theenergy delivery device means is a plurality of RF electrode means. 81.The apparatus of claim 80, wherein the plurality of electrode means is aflexible circuit means.
 82. The apparatus of claim 50, furthercomprising: a mechanical expansion device means coupled to theexpandable member means.
 83. A method of treating a sphincter,comprising: providing an expandable member sized to be positionable inthe sphincter and configured to non-permanently open the sphincter froma contracted configuration, and an energy delivery device coupled to theexpandable member; introducing the expandable member in the sphincter;dilating the sphincter from the contracted state; delivering sufficientenergy from the energy source to the sphincter to tighten the sphincter;and removing the expandable member from the sphincter.
 84. The method ofclaim 83, wherein the energy delivery device has a configuration thatcontrollably produces lesions an interior of the sphincter withoutcreating a permanent impairment of the sphincter's ability to achieve aphysiologically normal state of closure.
 85. The method of claim 83,wherein energy delivery device delivers sufficient energy to cause aproliferation of fibroblast cells in the sphincter.
 86. The method ofclaim 85, wherein the energy delivery device delivers sufficient energyto cause a proliferation of myofibroblast cells in the sphincter. 87.The method of claim 83, wherein the energy delivery device deliverssufficient energy to create a tightening of the sphincter withoutpermanently damaging anatomical structures near the sphincter.
 88. Themethod of claim 87, wherein the energy delivery device deliverssufficient energy to create a tightening of the sphincter withoutpermanently disrupting an aorta positioned near the sphincter.
 89. Themethod of claim 87, wherein the energy delivery device delivers asufficient amount of energy to create a tightening of the loweresophageal sphincter without permanently damaging a vagus nervepositioned near the sphincter.
 90. The method of claim 87, wherein theenergy delivery device delivers a sufficient amount of energy to createa tightening of the lower esophageal sphincter without permanentlydamaging an esophageal plexus of nerves and veins positioned near thesphincter.
 91. The method of claim 87, wherein the energy deliverydevice delivers a sufficient amount of energy to create a tightening ofthe lower esophageal sphincter while preserving a blood supply to thesphincter.
 92. The method of claim 83, wherein the energy deliverydevice creates a tightening of the lower esophageal sphincter whilecreating submucosal lesions in the sphincter.
 93. The method of claim83, wherein the expandable member is expandable.
 94. The method of claim73, wherein the expandable member is introduced in the lower esophagealsphincter in an unexpanded state.
 95. The method of claim 94, whereinthe expandable member is expanded to an expanded state when positionedin the sphincter.
 96. The method of claim 93, wherein the expandablemember is a balloon.
 97. The method of claim 93, further comprising: anelectrolytic solution housed in an expanded expandable member.
 98. Themethod of claim 83, wherein the energy delivery device is an RFelectrode.
 99. The method of claim 98, further comprising: an RF energysource coupled to the RF electrode.
 100. The method of claim 83, whereinthe energy delivery device is a microwave antenna.
 101. The method ofclaim 100, further comprising: a microwave energy source coupled to themicrowave antenna.
 102. The method of claim 83, wherein the energydelivery device is a waveguide.
 103. The method of claim 102, furthercomprising: a light source coupled to the waveguide.
 104. The method ofclaim 83, wherein the light source is a laser.
 105. The method of claim83, wherein the energy delivery device is an acoustical transducer. 106.The method of claim 105, further comprising: an acoustical energy sourcecoupled to the acoustical transducer.
 107. The method of claim 83,wherein the energy delivery device is a resistive heating device. 108.The method of claim 83, wherein the energy delivery device is deliveredto the sphincter transorally without an endoscope.
 109. The method ofclaim 83, wherein the energy delivery device is delivered to thesphincter with an endoscope.
 110. The method of claim 83, wherein thesphincter is the lower esophageal sphincter.